abbvie, aop-orphan, camurus, gl pharma, ferrer, harm reduction … · 2019. 12. 6. · abbvie,...

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06.12.2019 1 Univ. Prof. Dr. Gabriele Fischer Center of Public Health Department of Psychiatry & Psychotherapy [email protected] Harm reduction in drug addiction with special emphasis on women OPCAT Commission 3 Disclosure Funding received over the past 10 years from Abbvie, AOP-Orphan, Camurus, GL Pharma, Ferrer, Gilead, Indivior, Mundipharma, Lundbeck, Pfizer, Reckitt Benckiser (honorarium for travel expenses & delivery of speeches) In 2010, mental and substance use disorders constituted for 10.4% of the global burden of disease leading cause of years lived with disability among all disease groups the global direct and indirect economic costs of mental disorders are estimated at US $ 2.5 trillion (years 2010) indirect costs (US $ 1.7 trillion) are much higher than the direct costs (US$0.8 trillion) Mental disorders therefore account for more economic costs than chronic somatic diseases such as cancer or diabetes The economic costs of mental disorders A. Direct and indirect costs B. Impact on economic growth C. Value of statistical life Trautmann et al., 2016, EMBO reports

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Page 1: Abbvie, AOP-Orphan, Camurus, GL Pharma, Ferrer, Harm reduction … · 2019. 12. 6. · Abbvie, AOP-Orphan, Camurus, GL Pharma, Ferrer, Gilead, Indivior, Mundipharma, Lundbeck, Pfizer,

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Univ. Prof. Dr. Gabriele Fischer

Center of Public Health

Department of Psychiatry & Psychotherapy

[email protected]

Harm reduction in drug addiction with special emphasis on women

OPCAT Commission 3

Disclosure

Funding received over the past 10 years from

Abbvie, AOP-Orphan, Camurus, GL Pharma, Ferrer, Gilead, Indivior, Mundipharma, Lundbeck, Pfizer, Reckitt Benckiser (honorarium for travel expenses & delivery of speeches)

In 2010, mental and substance use disorders constitutedfor10.4% of the global burden of disease

� leading cause of years lived with disability among all disease groups

� the global direct and indirect economic costs of mental disorders are estimated at

US $ 2.5 trillion (years 2010)

� indirect costs (US $ 1.7 trillion) are much higher than the direct costs (US$0.8 trillion)

Mental disorders therefore account for more economic costs thanchronic somaticdiseasessuch ascanceror diabetes

The economic costs of mental disorders

A. Direct and indirect costs

B. Impact on economic growth

C. Value of statistical life

Trautmann et al., 2016, EMBO reports

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Economic burden

• Substance use disorders: €66 billion/year1

– €28 billion direct health-related costs

– €14 billion direct non-medical costs (expenses associated with the

delivery of health care & health services, e.g. transportation)

– €24 billion indirect costs (e.g., unemployment)

� WITHOUT costs related to criminality/justice system

Pharm. Treatment of opioid dependence: € 3.800 per patient/year

Costs per person/year in prison: €34.5002

�High societal costs not only caused by the severity of addictive

disorders but also by their close relation to criminal behaviour

1 Olesen et al. (2012). European Journal of Neurlogy 19(1): 155-162; 2 Metz et al. (2012b). Therapie statt Strafe. Gesundheitsbezogene Maßnahmen bei Substanzabhängigkeit und Suchtmittel(straf)recht. Vienna, Austria: NWV

Gender/sex differencesin addiction

• prevalence/incidence• age of onset• treatment access• comorbidity• consumption patterns• metabolism• secondary damage• mortality• abstinence behaviour

Men & Women are different

In addition also

� cultural background, ethnicity and economics play a major role

In the spectrum of medical diseases women do have a higher retention rate in all disorders, but not in substance use disorder - related to limited access to treatment.

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Wittchen et al, 2005.

Sex and mood disorders: prevalence

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Prevalence of psychiatric symptoms (n=174 pregnant women with substance use disorder)

Benningfield, M.M., Arria, A.M., Kaltenbach, K., Heil, S.H., Stine, S.M., Coyle, M.G., Fischer, G., Jones, H.E., Martin, P.R. Co-occurring Psychiatric Symptoms are Associated with Increased Psychological, Social & Medical Impairment in Opioid Dependent Pregnant Women. AM J Addict, 2010, 19(5): 416-421.

Psychiatric Symptoms In %

One or more psychiatric diagnosis 65

Major Depression (MDD) 32

Dysthymia 31

Hypomanic episode 39

Anxiety disorders

- Generalized anxiety disorder (GAD) 40

- Panic disorder 26

- Agoraphobia 22

Social Phobia 16

Post-traumatic Stress Disorder (PTSP) 16

Obsessive–compulsive disorder (OCD) 3

Bulimia <1

Symtoms at some point in the past 30 days

in %

Mood symptoms 49

Anxiety symptoms 40

Suicial thinking 13

Treatment

is a human right & not a priviledge

Human Rights Treaties - UN Principles

Convention on Elimination of Discrimination against Women

(CEDAW)

Covenant on Economic & Social & Cultural Rights (CE SCR)

Covenant on Civil & Political Rights (CCPR)

Universal Declaration of Human Rights (UDHR)

Convention on Elimination of

Racial Discrimination

(CERD)

Convention on the Rights of Persons with Disabilities

(CRPD)

Convention Against Torture (CAT)

“Bill of Rights”

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Convention on the Rights of Persons with Disabilities (CRPD)Quelle: United Nations. Abgerufen von https://www.un.org/development/desa/disabilities/convention-on-the-rights-of-persons-with-

disabilities.htmlam 13.3.2017 um 18:00.

Convention on the Rights of Persons with Disabilities(Art 1 CRPD)

Persons with disabilities include those who have long-term physical, mental*, intellectual or sensory impairments which in interaction with various barriers may hinder their full and effective participation in society on an equal basis with others.

*This includes of course: substance use disorder

= chronic relapsing psychiatric disorder

Obligation to ensure participation: Art 4/3 CRPD

In the development and implementation of legislation and policies to implement the present Convention and in other decision-making processes concerning issues relating to persons with disabilities,

States Parties shall closely consult with and actively involve persons with disabilities, including children with disabilities, through their representative organizations.

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Right to Health – Article 12 CESCR1. The States Parties to the present Covenant recognize the right of everyone to the enjoyment of the highest attainable standard of physical and mental health.

Benefits of Scientific Progress – Article 15 CESCR The States Parties to the present Covenant recognize the right of everyone:

(b) To enjoy the benefits of scientific progress and its applications (eg: positive discrimination – women as more marginalized group should benefit early & comprehensively on new medical options)

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Covenant on Economic, Social and Cultural Rights (CESCR)

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Pregnant women with substance use disorders

Ethical & legal guidelines

Convention on the Elimination of All Forms of Discrimination Against Women

(Right to Health – Article 12 CEDAW)

• States Parties shall take all appropriate measures to eliminate discrimination against women in the field of health care in order to ensure, on a basis of equality of men and women, access to health care services, including those related to family planning.

• (..) States Parties shall ensure to women appropriate services in connection with pregnancy, confinement and the post-natal period, granting free services where necessary, as well as adequate nutrition during pregnancy and lactation.

The Human Right for a reproductive Health

The rights of women “include their right to have control over and decide freely and responsibly on matters related to their sexuality, including sexual and reproductive health, free of coercion, discrimination and violence. http://www.ohchr.org/Documents/Issues/Women/WRGS/SexualHealth/INFO_Contra_FamPlan_WEB.pdf

Past month substance use among pregnant women 2018, US data

2018 National Survey on Drug Use and Health, SAMHSA

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Abused Prescription Opioids

Oxycodone (OxyContinR) Aspirin & Oxycodone (PercodanR)

Hydromorphone (DilaudidR, PalladoneR)Codeine

Tramadol

Fentanyl

ISC1

Best interest of the child (Art 3 Child Rights Convention)

1. Right

2. Legal principle

3. Procedural rule

Ad 1: Must be determined on a case-by-case basis

Ad 2: Resolve any conflicts with other human rights treaties (eg under consideration ESCR; CRPD..)

Ad 3: Attention must be paid to all solutions, which are in the child’s best interests (eg full information & disclosure to parents, including information on diagnosis & course of treatment)

Child Rights Convention -Determination of the child’s best interests:

Protection of the family has to be ensured (Right to Privacy, European Convention Human Rights-ECHR)

• Support for parents to fulfill their parental responsibilities

• Economic reasons no justification for separation (Art 10 ESCR)

• Child’s life and development have to be considered holistically

• Future consequences of decision have to be taken into account

• Decision making has to be fair & give due respect to parents’ views

• Non-discrimination: eg regarding health-status, social origin etc.

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ISC1 Dear Prof Fischer, we have added Tramadol, Codeine and Fentanyl and we re-arranged the layout slightly to accomodate the extra text. Please let us know if you are happy with this.Isabella SS. Cruz, 21/06/2017

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Human rights consideration in regard:opioid dependent/maintained pregnant

women & neonatesIn some countries/institutions women are forced to withdraw from methadone/burprenorphine during pregnancy:

• no scientific evidence in favour of forced withdrawal during pregnancy-contrary - “quasi-voluntary“: increased risk of mortality & morbidity

• sometimes institutions follow even an extortive approach: women have to “show treatment motivation” to be entitled to care for their child

� Practices against scientific evidence are not in line with the right of highest standard of care and the right of scientific progress .. � “methadone/buprenorphine maintenance” etc.

� See:The States Parties to the present Covenant recognize the right of everyone (…) to enjoy the benefits of scientific progress and its applications (…)1.

� Forced withdrawal during pregnancy could even lead to harm of the unborn child due to physical and psychological stress of the mother

1 Article 15, International Covenant on Economic, Social and Cultural Rights

Human rights concerns- examples

During the postpartal period, some institutions do not inform mothers about medication and diagnostic procedures concerning their new born. This is

seen critically, as the legal guardian has the right to full information about therapy and examinations concerning the child in order to give informed

consent.

� Implementation of the right to health1 must take into account all human rights principles, especially the guiding principles of the Convention, and must be shaped by evidence-based public health standards and best practices.2

� It is essential that supportive policies are in place and that children, parents and health workers have adequate rights-based guidance on consent, assent and confidentiality.2

1 Article 24, Child Rights Convention2 General Comment 15, Child Rights Committee, Right to Health

Sample: 8509 Boston Birth Cohort mother-newborn pairs for p renatal and perinatal analyses

- Overall, 454 of the 8509 children (5.3%) had in utero opioid exposure.

At birth, opioid exposure was associated

- with higher risks of fetal growth restriction (odds ratio [OR], 1.87; 95%CI, 1.41-2.47)

- Preterm birth (OR, 1.49; 95%CI, 1.19-1.86)

Sample: cont`d

Opioid exposure was associated with

- increased risks of lack of expected physiological development (OR, 1.80; 95%CI, 1.17-2.79)

- conduct disorder/emotional disturbance (OR, 2.13; 95%CI, 1.20-3.77) among preschool-aged children.

In school-aged children, opioid exposure was associ ated with

- a higher risk of attention-deficit/hyperactivity disorder (OR,2.55; 95%CI, 1.42-4.57)

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Costs of preterm deliveries in UK in €/ infant

Preterm delivery

(< 37 weeks)

Early preterm delivery

(< 33 weeks)

Very early preterm delivery

(< 28 weeks)

Prevalence of live births 7.17 1.71 0.48

Costs for delivery 443,- 974,- 2.425,-

Costs for neonatal care 28.993,- 79.447,- 116.230,-

Costs for inpatient treatment until age of 18 yrs 29.762,- 81.152,- 120.495,-

Costs for outpatient treatment until age of 18 yrs 761,- 1.104,- 2.187,-

Costs for medical and social care until age of 18 yrs

30.775,- 83.015,- 124.913,-

TOTAL 90.734,- 245.692,- 466.250,-

Mangham et al. 2009. The Cost of Preterm Birth Throughout Childhood in England and Wales. Pediatrics 123: e312-327

• Global prevalence of alcohol use during pregnancy:

9.8% (95% CI 8·9–11·1)

• Estimated prevalence of fetal alcohol syndrome (FAS) in thegeneral population: 14.6/10 000 people (95% CI 9·4–23·3)

� one in every 67 women who consumed alcohol during pregnancy delivers

a child with FAS

� 119 000 children born with FAS in the world every year

Health system costs of Fetal Alcohol Syndrome (US)

Mean costsper year(US$)

Additionalcosts per year

* (US$)

Potential cumulative savings per case and year (US$)

After 10 years After 20 years

FAS 2.842 2.342 128.810 491.820

ADHD 649 154 8.470 32.340

Learning disability 1.302 806 44.330 169.260

Developmentaldisorder

2.286 1.797 98.835 377.370

ODD** 1.377 883 48.565 185.430

Epileptic seizures 2.181 1.689 92.895 345.690

Health system costs of FAS and comorbid disorders (U S) until 21 years of age

*Additional costs: Costs of a child with the disorder minus costs of a child without the disorder**Opositional Defiant Disorder

Klug, M. G., & Burd, L. (2003). Neurotoxicology and teratology, 25(6), 763-765.

Thank you for your attention!

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